Kornimate/medical-research-clean huggingface dataset:
ozone therapy in the prevention of covid-19 infection

Conditions: Corona Virus Infection

Summary: coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. ozone therapy has become o promising tool for both prevention and treatment of covid-19 infection by various possible mechanisms. the oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of covid-19 infection. in recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. as a result of this, there were many individuals who had received ozone therapy before the outbreak of covid-19. this study aimed to investigate the preventive effect of ozone therapy against covid-19 infection in these individuals.

the inclusion criteria were determined to be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first covid-19 case of turkey reported (mar 11, 2020). individuals who received ozone therapy locally or fewer than ten sessions, who did not want to participate were excluded. the major autohemotherapy procedure to all the participants was applied as follows: 100ml of blood was drawn by a vacuum from the antecubital vein into a sterile glass bottle in which 12 ml of 3.13% sodium citrate solution as an anticoagulant (medipac®, germany). a corresponding volume (100ml) of gas with an ozone concentration of 10-20 µg/ml was immediately added and continuously mixed by a gentle rotating movement to avoid foaming to the blood in the bottle. ozone was produced by a blue-s medical ozone generator (turkozone®, turkey). reinfusion was accomplished in about 15-20 minutes, and the whole procedure was carried out in approximately 30 minutes and was repeated two or three times a week.

Eligibility criteria:
inclusion criteria: * to be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first covid-19 case of turkey reported (mar 11, 2020) exclusion criteria: * to received ozone therapy locally or fewer than ten sessions * not want to participate

Keywords: coronavirus ozone preventive medicine
study of the effect of the auditory stimulation on stuttering symptoms in patients with a deficit of spectral power in the eeg beta frequency band

Conditions: Stuttering, Adult; Stammering

Summary: in this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective eeg spectral power changes.

stuttering is a speech disorder that affects more than 70 million people worldwide, limiting their ability to communicate and socialize. during recent decades, several studies have demonstrated a link between stuttering and a deficit of β eeg spectral power. in this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective eeg spectral power changes. participants are adults with stuttering and without speech disfluencies from the control group will expose to euphonic binaural stimuli for 5 minutes. the brain electrical activity patterns (eeg) and ecg bio-signals will record prior to, during, and after exposure.

Eligibility criteria:
inclusion criteria: * adults with stuttering (stammering) symptoms; exclusion criteria: * hearing disabilities; * applying other drugs or devices simultaneously;

Keywords: speech disorders binaural beats auditory stimulation stuttering stammering
dialectical behavior therapy skills group pilot evaluation

Conditions: Suicidal Ideation; Emotions

Summary: uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of dialectical behavior therapy skills group for veterans with suicidal ideation and emotion dysregulation.

uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of dialectical behavior therapy skills group for veterans with suicidal ideation and emotion dysregulation. outcome measures will occur at pre-treatment, mid, end, and follow-up.

Eligibility criteria:
inclusion criteria: 1. veterans at vachs who are referred or self-referred to dbt skills group 2. ages 18-65 3. able to understand written and spoken english 4. ders score 105 or greater 5. suicidal ideation within past 3 months 6. seeing an individual mental health provider at vachs at least monthly 7. willing to create or review a mental health safety plan, and stated willingness to use this plan to maintain safety 8. consent to participate in study assessments 9. consent to recording of group sessions exclusion criteria: 1. inability to understand written or spoken english 2. diagnosis of schizophrenia, schizoaffective disorder, bipolar i, antisocial personality disorder, or thought disorder in cprs problem list and confirmed by current mental health provider
a study evaluating the long-term safety of vx-445 combination therapy

Conditions: Cystic Fibrosis

Summary: this study evaluated the long-term safety and tolerability of elexacaftor (elx), tezacaftor (tez), and ivacaftor (iva) triple combination (tc) treatment in participants with cystic fibrosis (cf).


Eligibility criteria:
inclusion criteria: * currently participating in study vx17-659-105 (nct03447262) exclusion criteria: * history of drug intolerance in study vx17-659-105 that would pose an additional risk to the participant in the opinion of the investigator * current participation in an investigational drug trial (other than study vx17-659-105) other protocol defined inclusion/exclusion criteria may apply.
immunotherapy for the treatment of breast cancer related upper extremity lymphedema (bcrl)

Conditions: Breast Cancer; Upper Extremity Lymphedema

Summary: the purpose of this study is to assess the efficacy of qbx258, a compound developed by novartis corporation composed of two antibodies, in reducing arm volume excess in women with stage i-ii breast cancer related lymphedema.


Eligibility criteria:
inclusion criteria: * women 18-70 with unilateral stage i or ii bcrl * volume difference of at least 300 ml between the normal and lymphedematous limb based on perometry evaluation * bmi of 18-30 * no current evidence of breast cancer * at least 6 months postop from axillary lymph node dissection exclusion criteria: * bilateral lymphedema or history of bilateral axillary lymph node dissection * recent history of cellulitis in the affected extremity (within last 3 months) * recurrent breast cancer or other malignancy * current (within last month) use of chemotherapy for breast or other malignancy * current (within last 3 months) use of radiation for breast or other malignancy * recent (within last month) or current intensive mld and/or short stretch bandage use * unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months) * pregnant or nursing (lactating) women * stage iii lymphedema * patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).

Keywords: qbx258 human monoclonal antibodies vak694 qax576 15-085
impact of ryaltris® nasal spray on patients' reported outcomes

Conditions: Allergic Rhinitis

Summary: a real world evidence study that aims to understand the impact of ryaltris® nasal spray in patients with allergic rhinitis over a 28-day period.

the aim of this research is to develop a greater understanding of satisfaction with ryaltris® nasal spray in patients with allergic rhinitis (ar). there is currently no real-world evidence for patient satisfaction data with ryaltris® nasal spray. to address this knowledge gap and add to clinically relevant data to support quality of life (qol) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a visual analogue scale (vas), following initiation of ryaltris® to explore the relationship between baseline and subsequent qol scores among patients initiated on ryaltris®.

Eligibility criteria:
inclusion criteria: ar patients (moderate-to-severe sar or par) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study: * patients above 18 years old * fluent in english * patients newly prescribed ryaltris® who have not yet initiated treatment * willing and able to provide consent to participate exclusion criteria: potential participants will be excluded if they: * are employed by a pharmaceutical company (to avoid conflict of interest) * are employed by a vaccine company (to avoid conflict of interest) * do not have access to the internet (to ensure validity of the data) * are unable to read and understand english (to ensure validity of the data) * are currently or have previously been on ryaltris®

Keywords: patient outcomes patient satisfaction quality of life
study of abbv-668 oral capsules to assess adverse events and change in disease activity in adult participants with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). this study will assess how safe and effective abbv-668 is in treating adult participants with uc. adverse events and change in disease activity will be assessed. abbv-668 is an investigational drug being developed for the treatment of moderate to severe uc. approximately 40 adult participants diagnosed with uc will be enrolled in approximately 30 sites globally. participants will receive oral capsules of abbv-668 twice daily for 52-weeks and will undergo a 30 day follow-up period. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis (uc) for at least 90 days prior to baseline. appropriate documentation of biopsy results consistent with the diagnosis of uc in the assessment of the investigator, must be available. * participant meets the following disease activity criteria: active uc with an adapted mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). * demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics) exclusion criteria: * current diagnosis of crohn's disease (cd) or inflammatory bowel disease-unclassified (ibd-u). * extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

Keywords: ulcerative colitis abbv-668
a study of gantenerumab in participants with prodromal alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (ro4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal alzheimer's disease. participants will be randomized to receive subcutaneous (sc) injections of either gantenerumab or placebo. participants who consent to be part of the sub study will undergo positron emission tomography (pet) scanning to assess brain amyloid. the anticipated time on study treatment is 104 weeks in part 1, with an option for an additional up to 2 years of treatment in part 2, followed by an open-label extension (part 3) until july 2020. the dosing for parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. the study has converted to open-label to investigate higher gantenerumab doses.


Eligibility criteria:
inclusion criteria: * adult participants, 50-85 years of age * participants with prodromal alzheimer's disease who are not receiving memantine or cholinesterase inhibitors * has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion * has had sufficient education or work experience to exclude mental retardation * study partner has noticed a recent gradual decrease in participant's memory (over the last 12 months), which the participant may or may not be aware of * screening mini mental state exam (mmse) score of 24 or above additional inclusion criteria for sub study: * able and willing to travel to pet imaging center and complete the planned scanning sessions * past and planned exposure to ionizing radiation not exceeding safe and permissible levels exclusion criteria: * other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning * a history of stroke * a documented history of transient ischemic attack within the last 12 months * history of schizophrenia, schizoaffective or bipolar disorder * currently meets criteria for major depression * within the last 2 years, unstable or clinical significant cardiovascular disease (myocardial infarction, angina pectoris) additional exclusion criteria for sub study: * inclusion in a research and/or medical protocol involving pet ligands or other radioactive agents within 12 months * present or planned participation in a research and/or medical protocol involving pet ligands or radioactive agents other than study wn25203 * have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid pet ligand would result in a cumulative exposure that exceeds local recommended exposure limits
evaluation of adipose derived stem cells exo.in treatment of periodontitis

Conditions: Periodontitis

Summary: the adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.


Eligibility criteria:
inclusion criteria: * advanced periodontitis (stage iii or iv) * healthy patients. exclusion criteria: * smokers, diabetic, pregnant ladies, under corticosteroids or contraceptive treatment,poor oral hygiene.

Keywords: periodontitis srp adscs exosomes treatment
atorvastatin ± aspirin in lynch syndrome syndrome

Conditions: Lynch Syndrome

Summary: the goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (crc) in high-risk individuals with lynch syndrome.

this is an exploratory biomarker trial to assess the ability of atorvastatin (common cholesterol lowering agent) alone or combining with aspirin (a nonsteroidal anti-inflammatory drug) to reduce the risk of colorectal cancer in high-risk individuals with lynch syndrome. subjects will be stratified based on their prior history of polyps/cancer to receive atorvastatin without or with aspirin for 6 weeks. blood and normal colon biopsies will be obtained at day 0 and at 6 weeks on study. tissue endpoints for analysis include cell proliferation, apoptosis and changes in gene expression. circulating lipid profiles and metabolic function, and post-treatment questionnaires will be used to assess the acceptability of the study.

Eligibility criteria:
inclusion criteria: * subjects who are 18 years of age or older * able to read and sign an informed consent document in english * eligible subjects will have molecular evidence of lynch syndrome (mutation in mlh1, msh2, msh6, epcam or pms2) * history of colorectal cancer if surgically cured and \> 1 year from completion of adjuvant chemotherapy exclusion criteria: * are \<18 years of age * unable to read and sign an informed consent document in english * have active cancer or are less than 3 years post hormonal maintenance therapy for cancer * have statin intolerance or contraindication for aspirin or atorvastatin use * are pregnant or are actively breast feeding

Keywords: hnpcc mlh1 msh2 msh6 pms2 epcam lynch
improving the health care in inflammatory bowel disease.

Conditions: Crohn Disease; Colitis, Ulcerative

Summary: inflammatory bowel disease (ibd) refers to two chronic diseases (crohn's disease and ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. traditionally ibd patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. lately there has been a shift in the health care service from conventional follow - up (cf) to a rising numbers of health care models in term of multidisciplinary team (mdt) also including care for ibd patients. mdt- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. patients have directly access to the ibd nurse who performing independently consultations at the ibd - policlinic. this study will test the hypothesis that mdt including an ibd - nurse is preferable concerning; patient reported health related quality of life (hrqol) quality of care (qoc), and clinical outcomes including adherence. this will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. data will be collected from medical records and patient questionnaires. investigators plan involving 300 participants aged \>18 and \< 80 recruited from medical departments in north norway and from diakonhjemmet in oslo. half will be from cf-models and half from the ibd - mdt. the study have approval from the local ethics committee and application to the data protection officer has been submitted. all participants are asked for provide written consent. the results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. in a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. a well-established mdt can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.


Eligibility criteria:
inclusion criteria: * diagnose duration \> 2 years, to ensure that the patients have some experience with ibd and their follow-up system, respectively exclusion criteria: * non-norwegian patients who will have difficulties understanding the questionnaires * patients with cognitive disabilities

Keywords: ibd hrqol qoc adherence ibd nurse mdt
electronic brachytherapy for the treatment of nmsc

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma

Summary: the objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the xoft axxent electronic brachytherapy system. additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the xoft axxent electronic brachytherapy system and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.

the objective of this study is to record local recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the xoft axxent electronic brachytherapy system. additional objectives include evaluate the cosmetic outcomes in patients treated for nonmelanoma skin cancer using the xoft axxent electronic brachytherapy system and record the occurrence of radiation therapy related skin toxicities in patients treated for nonmelanoma skin cancer using the xoft axxent electronic brachytherapy system.

Eligibility criteria:
inclusion criteria: * patient has signed the informed consent form * pathological diagnosis confirmed of squamous cell or basal cell carcinoma * histopathological grade: g1 (well differentiated), g2 (moderately differentiated), or gx (not assessed in report) * clinical staging tis, t1, or t2 (must be ≤ 4 cm in diameter) * one lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins. exclusion criteria: * t2 \> 4 cm and t3 and t4 * american joint committee staging for nmsc stages iii and iv * histopathologic grade 3 (poorly differentiated) or higher grade * target area is adjacent to a burn scar * target area is on the lip * patient \< 50 years of age * any prior definitive surgical resection of the cancer * perineural invasion * lesion depth \> 5mm on clinical assessment or as assessed by ultrasound or ct. * patient is pregnant (pregnancy test required if standard of care). * target area is prone to trauma. * target area with compromised lymphatic or vascular drainage. * participation in another investigational device or drug study concurrently. * patient has undergone prior radiation therapy to this specific anatomic location. * patient is receiving pharmacologic agent(s) at or around the time of the radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study. * patient is receiving chemotherapeutic agent(s) six (6) weeks before or six (6) weeks after radiation therapy. * life expectancy less than five (5) years.

Keywords: electronic brachytherapy nonmelanoma cancer
a study to evaluate the long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa (HS)

Summary: the purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent phase 3 studies (incb 54707-301 \[nct05620823\] or incb 54707-302 \[nct05620836\]).


Eligibility criteria:
inclusion criteria: * completion of the study treatment period of the originating parent study (incb 54707-301 or incb 54707-302). * agreement to use contraception. * willing and able to comply with the study protocol and procedures. * further inclusion criteria apply. exclusion criteria: * participation in the extension study could expose the participant to an undue safety risk. * women who are pregnant (or who are considering pregnancy) or breastfeeding. * further exclusion criteria apply.

Keywords: hidradenitis suppurativa hidradenitis acne inversa hs povorcitinib long-term extension (lte) incb054707